Cleared Traditional

Velox Nebulizer System

K162785 · Pari Respiratory Equipment, Inc. · Anesthesiology
Apr 2017
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K162785 is an FDA 510(k) clearance for the Velox Nebulizer System, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on April 14, 2017, 193 days after receiving the submission on October 3, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K162785 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2016
Decision Date April 14, 2017
Days to Decision 193 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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